FDA 483 - Biogen MA Inc. - June 16, 2021
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
An FDA inspection of Biogen Inc.'s drug substance manufacturing facility in Research Triangle Park, NC, revealed significant deficiencies across multiple quality systems. Observations included inadequate documentation for training samples, poor maintenance of equipment and facilities, and failures in contamination control. The firm also lacked complete method validation for bioburden detection, had an inadequately specified GMP utility, and demonstrated non-adherence to several standard operating procedures.
ID · dfe6f839-66e9-4a58-a0a1-2ea8cf68f2b9